• Title/Summary/Keyword: Good Clinical Practice

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Adaptation of Intravenous Infusion Nursing Practice Guideline (정맥주입요법 간호실무지침 수용개작)

  • Gu, Mee Ock;Cho, YoungAe;Cho, Myung Sook;Eun, Young;Jeong, Jae Sim;Jung, Ihn Sook;Lee, Young Geun;Kim, Mi Kyung;Kim, Eun Hyun;Kim, Ji Haei;Lee, Sun Hee;Kim, Hyun Lim;Yun, Hee Sook
    • Journal of Korean Clinical Nursing Research
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    • v.19 no.1
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    • pp.128-142
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    • 2013
  • Purpose: This study was conducted to adapt the previously developed intravenous infusion guidelines with good quality for development of the evidence-based intravenous infusion nursing practice guideline in Korea. Methods: Guideline adaptation process was conducted according to guideline adaptation manual version 2.0 developed by NECA (Kim, Kim et al., 2011) which consisted of three main phases, 9 modules including a total of 24 steps. Results: Adapted intravenous infusion nursing practice guideline was consisted of 19 domains and 180 recommendations. The domains and number of recommendations in each domain were: general guide, 4; assessment, 1; vascular access device selection, 4;site selection, 14;site preparation, 5;site care, 29; maintaining patency, 11; blood sampling via vascular access, 4; vascular access device exchange and removal, 9; add-on device selection, 27; infusion related complications, 63; education, 7; and documentation and report, 2. There were 11.9% of A, 28.4% of B, 58.7% of C in grade of recommendations. Conclusion: Adapted intravenous infusion nursing practice guideline is expected to contribute providing an evidence based practice guides for intravenous infusion. The guideline is recommended to be disseminated to nurses nationwide to improve the efficiency of intravenous infusion practice.

The effect of acupuncture on hot flushes : A study protocol of multi-center randomized controlled clinical trial (갱년기 여성의 안면홍조에 대한 침치료 다기관 임상시험 : 프로토콜)

  • Park, Ji-Eun;Oh, Dal-Seok;Kang, Kyung-Won;Kim, Dong-Il;Choi, Sun-Mi
    • Korean Journal of Acupuncture
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    • v.24 no.3
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    • pp.33-45
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    • 2007
  • Background : Hot flushes are general postmenopausal symptoms which about 75% of climacteric women undergo. They affect hotness, perspirations, systemic weakness, panic disorders, insomnia. Acupuncture is effective in alleviating hot flushes in practice. Assessment effectiveness and safety of acupuncture in hot flushes would be needed through multi-center trial. Objectives : Purpose of this study is to develope the protocol of effects of acupuncture on hot flushes, a postmenopausal symptom in climacteric women. Methods & Results : It will be a multi-centered, randomized, sham controlled, comparative trial. It will be performed by Good Clinical Practice after approval of Institutional Review Board. Selection criteria will be set according those of FDA above moderate degree. There will be a notice on concomitant medication, other herbs, dietary supplements. Superficial needling on sham points will be used for control group. Treatment period will be 8 weeks with 12 weeks' follow up. Some questionnaire scale will be used as the primary and secondary outcome. Conclusions : The clinical trials based on this protocol will be performed.

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The Job Performance, Importance, and Difficulty in Surgical Clinical Practice Nurses using Importance-Performance Analysis (중요도-수행도 매트릭스 분석 기법을 활용한 외과계 임상전담간호사의 업무 수행도, 중요도, 난이도)

  • Jung, Ji hye;Ha, Yeongmi
    • Journal of Korean Clinical Nursing Research
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    • v.29 no.1
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    • pp.121-134
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    • 2023
  • Purpose: The purpose of this study was to describe the job performance, importance, and difficulty in Surgical Clinical Practice Nurses (SCPNs), and to identify the priority of job tasks using Importance-Performance Analysis (IPA). Methods: One hundred SCPNs were recruited from two university hospitals and two general hospitals during November 2021 to April 2022. A total of 97 data were analyzed excluding 3 data due to missing responses. The data were analyzed by two groups, with Ward-Based SCPNs (W-SCPNs) and Operation Room-Based SCPNs (OR-SCPNs) according to different characteristics of job tasks. Results: There were differences of job performance between W-SCPNs and OR-SCPNs. As a result of the IPA, tasks of 'working practices in the ward' for W-SCPNs and those of 'surgery and treatments' for OR-SCPNs were included in the first quadrant (keep up the good work). 'Resarch' and 'leardership' were included in the third quadrant (low priority). Conclusion: Since there are differences in job tasks between W-SCPNs and OR-SCPNs, health care institutions should consider the differences in defining the scope of job performance. Furthermore, it is necessary to develop customized continuing education program based on our findings of IPA.

The effects of Inter-professional Patient Safety Education in clinical practice for healthcare college students (보건의료계열 대학생 대상 전문직 간 환자안전 교육프로그램이 임상실습에 미치는 효과)

  • Shin, Eunhee
    • Journal of Digital Convergence
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    • v.17 no.11
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    • pp.409-417
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    • 2019
  • This study was done to identify the effects of the inter-professional education program on the knowledge, attitude, and self-confidence of patient safety in the clinical practice of nursing, physical therapy and biomedical laboratory students. Each week for 6 weeks, a lecture and group discussion were given to twenty-nine students. Data were collected by self-administered questionnaire and interview. The knowledge and self-confidence were increased but the attitude was not changed. Students showed the increased their awareness of patient safety and the importance of collaboration with other occupational groups. It is necessary to establish a inter-professional education program between departments to enhance the ability to work collaboratively based on good communication along with knowledge, attitude in clinical settings.

Systematic Review of Clinical Research on Daegunjoong-tang for Improvement of Gastrointestinal Motility after Surgery for Gastrointestinal Cancer (소화기암 수술 후 위장관 운동성 개선을 위한 대건중탕의 효과에 대한 임상연구의 체계적 문헌고찰)

  • Han, Ga-jin;Seong, Sin;Kim, Sung-su
    • The Journal of Internal Korean Medicine
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    • v.38 no.6
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    • pp.980-999
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    • 2017
  • Objectives: This study aimed to evaluate the efficacy of Daegunjoong-tang for improvement of gastrointestinal motility after surgery due to gastrointestinal cancer by analyzing the existing clinical research. Methods: Clinical studies about Daegunjoong-tang for improvement of gastrointestinal motility after surgery due to gastrointestinal cancer were identified in a literature search using the search term "Daikenchuto AND cancer AND ileus." The studies were analyzed in terms of design, inclusion and exclusion of participants, intervention, control, outcomes, and results. Results: Nine articles were identified in the literature search. Four trials included colon cancer participants with colectomy, and three studies included gastric cancer with total gastrectomy. The intervention in each case was Daegunjoong-tang, and most interventions were made by a pharmaceutical company with a Good Manufacturing Practice facility. The most frequently used control was a placebo. The methods were diverse, including measuring gastrointestinal function, motility, quality of life, symptom scores with a numeric rating scale, and blood tests. Safety was investigated by recording adverse events. Conclusions: Some issues were discovered by reviewing the existing clinical research about Daegunjoong-tang for improvement of gastrointestinal motility after surgery for gastrointestinal cancer. These results will be utilized as evidence for using Daegunjoong-tang in clinical practice and designing a clinical trial for Korean patients.

A 6-Week Oral Toxicity Study of Oral Cholera Vaccine in Sprague-Dawley Rats

  • Baek, Yeong-Ok;Choi, Seuk-Keun;Shin, Seo-Ho;Koo, Kyo-Hwan;Choi, Ho-Young;Cha, Seung-Bum;Li, Yong-Chun;Yoo, Hyeon-Jeong;Lee, Joo-Young;Kil, Ki-Hyun;Kim, Hak-Soo;Kang, Min-Soo;Kang, Boo-Hyun;Kim, Kap-Ho;Bae, Jin-Sook
    • Toxicological Research
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    • v.28 no.4
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    • pp.225-233
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    • 2012
  • The present study was carried out to examine the toxicity and target organs of oral cholera vaccine (OCV) after repeated oral administration in Sprague-Dawley rats for 6 weeks (3 administrations, once every 2 weeks). OCV is an inactivated oral cholera vaccine that contains Vibrio cholerae and confers protection against cholera caused by V. cholera serogroups O1 (Inaba and Ogawa serotypes) and O139 (strain 4260B). The animals were orally administered either OCV placebo (negative control) or OCV at a dose equivalent to 240 times the anticipated human dose. Throughout the administration period, no significant change was detected in clinical signs, body weight, food or water consumption, urinalysis results, hematological and clinical biochemistry test results, organ weights, necropsy, or histopathological examination results. Minor changes were found in hematological and clinical biochemistry tests; however, these changes were within normal ranges. The above results suggest that oral administration of OCV in rats did not induce any toxicologically meaningful changes, and the target organs could not be determined. This study was conducted in accordance with the guidelines established by Good Laboratory Practice (2009-183, KFDA, December 22, 2009) and the OECD Principles of Good Laboratory Practice (1997).

Simulation-based Clinical Judgment and Performance Ability for Tracheal Suction in Nursing Students (간호대학생의 시뮬레이션실습 기반 임상판단력과 흡인간호수행능력)

  • Lim, Kyung-Choon
    • The Journal of Korean Academic Society of Nursing Education
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    • v.23 no.3
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    • pp.330-340
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    • 2017
  • Purpose: This study was conducted to explore the relationship between simulation-based clinical judgment and performance ability for tracheal suction in nursing students. Methods: With a convenience sampling, 207 nursing students participated in this descriptive study. Lasater clinical judgment rubric was used for self-reported clinical judgment in addition to observe the skill of tracheal suction using a checklist. Data were analyzed by descriptive statistics, t-test and Pearson's correlation coefficients using the SPSS/WIN 22. Results: A scenario with pneumonia patient was developed to observe the skill of tracheal suction during simulation-based practices. Then self-reported clinical judgment was scored. The mean score of total sum of clinical judgment, total mean of clinical judgment, and performance skill were $36.44{\pm}4.82$, $13.44{\pm}1.71$, and $42.32{\pm}5.05$, respectively. Statistically, students having good skills in suction showed significant differences in clinical judgment of interpreting (p=.031) compared to students having fair skills. Conclusion: The results of this study show that a structured debriefing method utilizing Lasater clinical judgment rubric is helpful. Also, simulation-based practice related to adult nursing in the respiratory system was useful for increasing the core basic skills among nursing students.

Influence of Clinical practice stress and Stress coping type on Self-leadership of Nursing students (간호대학생의 임상실습스트레스와 스트레스 대처방식이 셀프리더십에 미치는 영향)

  • Jo, Eun-Joo;Kang, Jung-Mi;Lim, Kyoung-Min
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.18 no.3
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    • pp.94-104
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    • 2017
  • This study was conducted to identify the influence of clinical practice stress and the stress coping type on the self-leadership of nursing students. The subjects were 122 nursing students in B city and the data were collected from May 6 to May 13, 2015. The data were analyzed by means of the t-test, ANOVA, Scheff's test, Pearson's correlation coefficients and Stepwise multiple regression. Significant differences were found in the self-leadership by health status (p<.001), interpersonal relationships (p=.001), satisfaction with nursing major (p<.001) and satisfaction with clinical practice (p=.002). Self-leadership was negatively related to clinical practice stress (p=.028) and positively related to stress coping style (p<.001). The meaningful variables which influenced self-leadership were the health status, stress coping type and satisfaction with nursing major. The total explanatory power was 28.1% and the health status was the most influential factor. Therefore, in order to enhance the self-leadership of nursing students, it is necessary for them to maintain a good health condition and to have an effective stress coping type. In addition, methods are needed to increase the satisfaction of nursing major students.

Comparison of Current GCPs on the Basis of the Contents in ICH-GCP (ICH-GCP와 선진 각국의 GCP 비교)

  • 박혜연
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 1997.11a
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    • pp.57-74
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    • 1997
  • To make a proposal for the revision of KGCP, ICH Harmonized Tripartite Guideline for Good Clinical Practice, which is on the stage of worldwide implementation, was compared with current GCPs of tripartite countries of ICH, namely USA, Europe and Japan as well as Korea. On the basis of the classification in ICH GCP, comprehensive comparisons among the corresponding articles of 4 regions or countries were made in the order of IRB / IEC, Investigator, Sponsor and Clinical Trial Protocol. Based on the comparisons of the contents in ICH-GCP with those in current GCPs, major suggestions for the revision of current KGCP can be made as follows. Firstly, the function of IRB / IEC needs to be strengthened for the initiation and continuation of clinical trial. Current 2-step approval system of IRB / IEC and Health Authorities requires to be converted into the system similar to that of developed countries. Secondly, sponsor's obligation needs to be tightened to control and assure the quality of clinical trial. Inspection of regulatory authorities should be made to perform during and / or after clinical trial, when it is necessary. In other words, sponsor should be made to establish written Standard Operating Procedures (SOPs) for all aspects of clinical trial including monitoring to ensure that trials are conducted and data are generated, documented, and reported in compliance with the protocol, GCP, and the applicable regulatory requirement (s). Besides, the provision of ‘Quality Control and Quality Assurance’ should be added to the protocol to establish the credibility of the result of the clinical trial.

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Controversies in Usefulness of EEG for Clinical Decision in Epilepsy: Pros. and Cons. (간질 치료에서 뇌파의 임상적 유용성에 관한 논란: 긍정과 부정적 관점에서)

  • Park, Soochul
    • Annals of Clinical Neurophysiology
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    • v.9 no.2
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    • pp.59-62
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    • 2007
  • Electroencephalogram (EEG) is an indispensable tool for diagnosis of epilepsy and is the only assisting barometer of complete remission of epilepsy, which means prolonged, persistent suppression of cortical excitement in epileptic focus in addition to the clinical control of epileptic seizure. The specific morphologies or distribution of epileptic form discharges give us good information for the classification of seizure or epilepsy and epileptic syndromes, which consists of "Pros." in terms of diagnostic approach. In contrast, the EEG as a tool for long-term follow up might be limited due to the various clinical situation of each patient, which consists of "Cons." in terms of the usefulness of EEG for clinical decision. "Cons." aspect of EEG, which clinicians are more frequently coped with than those of "Pros", is an obstacle of utilization of follow up EEG in clinical practice. This is an overview about controversies in usefulness of EEG and the detailed aspects of "Pros." and "Cons." of EEG for clinical decision will be discussed following two articles. We tried to make consensus for the usefulness of EEG especially in the situation of "Cons." with plausible guideline.

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